Relugolix to improve PSMA PET/CT imaging in men with high or very high risk prostate cancer
Phase 2 Randomized Study to Assess Use of Androgen Deprivation to Enrich PSMA Expression and Improve Sensitivity of Staging PSMA PET/CT: The EnrichPSMA Trial
We are testing whether a short course of relugolix can boost PSMA levels and make PSMA PET/CT scans better at finding cancer in men with high or very high risk prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT07025369 on ClinicalTrials.gov |
What this trial studies
This randomized phase II trial uses flotufolastat F-18 (POSLUMA) PET/CT scans before and after a short course of relugolix to measure changes in PSMA uptake. Patients are randomized to one of three arms, including two short-course relugolix schedules (5 days or 10 days) with pre- and post-treatment PET/CT and a comparator arm. The primary endpoint compares SUVmax and SUVmean of the dominant primary prostate lesion pre- versus post-ADT; secondary endpoints include lymph node sensitivity and PSMA avidity on PET/CT. Participants typically undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of the second PET/CT, and blood and tissue biospecimens are collected for correlative analyses.
Who should consider this trial
Good fit: Ideal participants are adult men with histologically confirmed high or very high risk prostate adenocarcinoma who are surgical candidates, have testosterone ≥300 ng/dL, ECOG 0–2, and adequate blood counts.
Not a fit: Men with low-risk disease, those already receiving ADT, those with low baseline testosterone, or patients who are not candidates for radical prostatectomy are unlikely to benefit.
Why it matters
Potential benefit: If successful, brief relugolix treatment could make PSMA PET/CT scans better at finding primary tumors and nodal spread, improving preoperative staging and treatment planning.
How similar studies have performed: Preclinical data and some clinical reports indicate androgen suppression can increase PSMA expression and alter PET signal, but using short-course relugolix specifically to improve PSMA PET/CT detection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age ≥ 18 years
* Histological confirmation of prostate adenocarcinoma
* Diagnosis of high risk or very high risk prostate cancer per National Comprehensive Cancer Network (NCCN) Risk Stratification. \[Any of the following: grade group 4 or 5, prostate-specific antigen (PSA) greater than 20, radiographic cT3 on MRI\]
* Testosterone greater than or equal to 300
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Hemoglobin ≥ 9.0 g/dL (obtained ≤ 120 days prior to registration/randomization)
* Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 120 days prior to registration/randomization)
* Platelet count ≥ 100,000/mm\^3 (obtained ≤ 120 days prior to registration/randomization)
* Male patients who are committed to undertaking the following measures for the duration of the study and after the last dose of ORGOVYX (relugolix) for the time period specified:
* Use a condom during sex while being treated and for 30 days after the last dose of ORGOVYX (relugolix)
* Do not make semen donations during treatment and for 30 days after the last dose of ORGOVYX (relugolix)
* Those with female partners of childbearing potential may be enrolled if they are:
* Documented to be surgically sterile (i.e., vasectomy);
* Committed to practicing true abstinence during treatment and for 30 days after the last ORGOVYX (relugolix) dose; or
* Committed to using an effective method of contraception with their partner during treatment and for 30 days following the last dose of ORGOVYX (relugolix)
* Provide written informed consent
Exclusion Criteria:
* Any of the following prior therapies:
* Chemotherapy ≤ 2 weeks prior to registration/randomization
* Androgen deprivation therapy
* Pelvic radiation
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Or psychiatric illness/social situations that would limit compliance with study requirements
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* Other active malignancy ≤ 1 year prior to registration
* EXCEPTIONS: Non-melanotic skin cancer
* NOTE: If there is a history of prior malignancy, they must not be receiving other active treatment for their cancer
* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
* Use of P-glycoprotein inhibitors
Where this trial is running
Scottsdale, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Jack R. Andrews, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.